Friday, February 04, 2011

Should FDA Have Approved Contrave for Obesity Because Docs Are Too Stupid to Use the Generic Components Off-label?

As reported in the WSJ Health Blog, FDA said it wouldn’t consider approving the experimental weight-loss drug Contrave without another clinical trial. FDA's decision comes after an FDA advisory panel voted in December to recommend approval of the drug.

Many pundits consider this another example of how risk-averse the FDA has become and how its decisions are hampering innovation. Even critics of the drug industry like Dr. Carlat claim that FDA's Contrave decision was a "Big Mistake" (see here).

Why does Carlat think it was a mistake when Contrave "is simply a combination" of two generics -- burpropion (Wellbutrin) and naltrexone -- that have been available for a long time? He says "Combining Wellbutrin and naltrexone was not something the average doctor would have ever thought of for an obesity treatment, so this counts as an uncommon example in which a company had a bright and non-trivial idea for a combination of two existing products."

Carlat didn't exactly say that doctors are too stupid to combine generics but a commenter said "the fact that the average doc might not have thought of it implies we need more effective dissemination of such info, not a new commercial product. Or are you thinking the inevitable TV ads might be a good way to get us all up to speed?"

Ha Ha! Good one! As if branded TV ads would alert doctors that the drug is actually a combination of two generics. They'd have to read the small print of the package insert to realize that. But advertising ANY treatment for obesity might make doctors who prescribe the treatment appear smarter.

BiDil is an example of a failed combo-drug the FDA DID approve (for heart failure). It didn't sell well despite advertising (see "BiDil Sales Disappoint: Blame Genes or Marketing?") perhaps because doctors were already smart enough to prescribe the cheaper generic components of the drug.

Carlat also said "The good news is that patients can ask doctors to prescribe them the constituents of Contrave, both of which are available in generic form -- burpropion and naltrexone. Presumably, this generic combination will be much cheaper than Contrave's pricing anyway!"

Obesity is a big problem here in the U.S. and elsewhere. The drug industry is looking to capitalize on that by introducing new drugs to treat obesity. Unfortunately, instead of investing in research, many companies are going after low-hanging fruit like combo drugs or actually cutting their research budgets to shore up stock prices (see, for example, "Pfizer Inc: Working Together for a Healthier Investor™").

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About the Author

Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own.